Randomized Phase 2 Trial of Pre-chemotherapy Leukine vs. Leukine-Dexamethasone in Combination With Gemzar & 5-FU in Patients With Metastatic Renal Cell Carcinoma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00176280|
Recruitment Status : Withdrawn (Slow accrual)
First Posted : September 15, 2005
Last Update Posted : June 18, 2015
-Overall study design: A randomized Phase II study in patients with metastatic RCC Patients will receive chemotherapy with gemcitabine and 5-FU. Prior to each chemotherapy the patient will receive a combination of Leukine alone (study cohort 1) or Leukine-dexamethasone (study cohort 2).
-Chemotherapy: gemcitabine 1.0 g/m2 intravenously (infused in the vein)over 30 minutes on Days 7 and 21, Folinic acid 200 mg/m2 on Days 7-8 and 21-22, then 5-FU 400 mg/m2, intravenously (infused in the vein) over 30 minutes followed by 5-FU 600 mg/m2 intravenously (infused in the vein) over 24 hours.
- Cohort 1, Leukine, 250 ug/m2 daily (8 am) subcutaneously (under the skin) on days 1, 2, 3, 4, 5 and 15, 16, 17, 18, and 19;
- Cohort 2, Leukine, 250 ug/m2 daily (8 am) subcutaneously (under the skin)on days 1, 2, 3, 4, 5, and 15, 16, 17, 18, and 19 and dexamethasone 12 mg every 12 hours (8 am and 8 pm) orally (by mouth) on days 3, 4, 5, 6, 7, 17, 18, 19, 20, and 21.
|Condition or disease||Intervention/treatment||Phase|
|Renal Cell Carcinoma||Drug: Leukine Drug: Dexamethasone||Phase 2|
- Determine the response rates and overall survival in patients with metastatic renal cell carcinoma (RCC) receiving pre-treatment with Leukine-dexamethasone vs Leukine alone in combination with gemcitabine-5-FU.
- Determine if pre-treatment with the combination of Leukine-dexamethasone is more effective than pre-treatment with Leukine alone in reducing the hematopoietic and non-hematopoietic toxicities of gemcitabine-5-FU in patients with metastatic RCC.
- Determine the effects of the combination of Leukine-dexamethasone vs Leukine alone on the number and function of peripheral blood dendritic cells, and cytokine levels when given prior to gemcitabine-5-FU in patients with metastatic RCC.
- Determine quality of life and toxicity of treatment in patients with metastatic RCC receiving pre-treatment with Leukine-dexamethasone vs Leukine alone in combination with gemcitabine-5-FU.
- Determine the dose intensity administered in both treatment groups.
- Overall study design: A randomized Phase II study in patients with metastatic RCC Patients will receive chemotherapy with gemcitabine-5-FU. Patients will receive prior to each chemotherapy the combination of Leukine alone (Cohort 1) or Leukine-dexamethasone (Cohort 2).
- Patient eligibility: a) chemotherapy naive patients with biopsy proven RCC, b) PS (ECOG), 0, 1, or 2, c) measurable disease by RECIST criteria, d) previous immunotherapy and anti-angiogenic therapy is allowed, e) adequate bone marrow, renal and hepatic function as defined by AGC > 1500 and PLC > 100,000 mm3 and serum creatinine and bilirubin < 1.5 mg/dl.
- Chemotherapy: Cohorts 1 and 2: Days 7 and 21: gemcitabine 1.0 g/m2 intravenously over 30 minutes; Days 7-8 and 21-22: Folinic acid 200 mg/ m2, then 5-FU 400 mg/ m2, intravenously over 30 minutes followed by 5-FU 600 mg/ m2 intravenously over 24 hours.
- Cohort 1, Leukine, 250 ug/m2 daily (8 am) subcutaneously days 1, 2, 3, 4, 5, and 15, 16, 17, 18, and 19;
- Cohort 2, Leukine, 250 ug/m2 daily (8 am) subcutaneously days 1, 2, 3, 4,5, and 15, 16, 17, 18, and 19 and dexamethasone 12 mg every 12 hours (8 am and 8 pm) orally days 3, 4, 5,6, 7, 17, 18, 19, 20, and 21.
- Evaluations during this trial: Baseline: history and physical examination with vital signs/weight, estimation of performance status (PS), CAT scans of chest, abdomen and pelvis, EKG, CBC/differential, urinalysis, complete biochemistry profile (CMP) (12 component) and quality of life assessment. Prior to each course: interim history, physical examination with vital signs/weight, grading of all toxicities, and estimation of PS, CMP, and CBC/differential. Prior to course 3, 5, and thereafter (every other course): CAT scans of chest, abdomen, and pelvis, tumor response and quality of life assessment. Each week after initiation of study (ie day1, course 1): CBC/differential, x 3 (Monday Wednesday and Friday). Biologic studies to include assessment of dendritic cell number and function (20 ml blood), days 1 and 7 of course 1.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized Phase II Trial of Pre-chemotherapy Leukine vs. Leukine-Dexamethasone in Combination With Gemcitabine and 5-Fluorouracil (5-FU) in Patients With Metastatic Renal Cell Carcinoma (RCC)|
|Study Start Date :||September 2005|
- % of subjects with CR or PR evaluated after course 2 then every other course using RECIST for both cohorts
- Survival (assessed until death)
- QOL (evaluated after courses 3 & 5 then every other course)
- % of subjects with >/= grade 3 hematopoietic & non-hematopoietic toxicities (assessed 3/week on treatment & continuing until counts recover)
- Days with <AGC 500 & platelet (PLC)< 20K mm3, # of febrile neutropenia hospital days, # of transfusions, bleeding & # of outpatient antibiotic days (assessed 3/week on treatment then until counts recover)
- Levels of peripheral blood dendritic cell # & function, plasma levels of cytokines including VEGF & TNF alpha (performed on days 1 & 7 of treatment)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00176280
|Study Chair:||John Rinehart, MD||University of Kentucky|